Edwards Lifesciences, LLC: Medical Device Recall in 2020 - (Recall #: Z-1928-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.

Product Classification:

Class II

Date Initiated: October 7, 2019

Date Posted: May 20, 2020

Recall Number: Z-1928-2020

Event ID: 85409

Reason for Recall:

Intermittent communication due to inconsistent crimping of connectors onto cables.

Status: Terminated

Product Quantity: 35

Code Information:

The cables with the following serial numbers (35) are recalled: 13710131, 13710130, 13710129, 13710115, 13710113, 13710025, 13710027, 13710028, 13710029, 13710030, 13710031, 13710041, 13710043, 13710045, 13710050, 13710051, 13710056, 13710057, 13710058, 13710061, 13710062, 13710063, 13710064, 13710066, 13710069, 13710070, 13710084, 13710086, 13710089, 13710092, 13710093, 13710094, 13710098, 13710099, 13710100.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of AL, CA, FL, IL, IN and MO, and the countries of Germany, Netherlands, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated